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Trial record 43 of 317 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Psychometric Properties of Sit-to-stand Test in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03625193
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sugalya Amatachaya, Khon Kaen University

Brief Summary:
  1. Do different arm placements (including arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) influence outcomes of sit-to-stand test (STST) in ambulatory individuals with spinal cord injury (SCI)?
  2. What are the factors associated with ability to perform STST in ambulatory individuals with SCI?
  3. Are the single-time sit-to-stand test (STSST) and five-time sit-to-stand test (FTSST) reliable, valid and responsive to determine functional alteration in ambulatory individuals with SCI?

Condition or disease
Spinal Cord Injuries

Detailed Description:
  • To cross-sectionally compare characteristics (duration and amount of lower limb loading) of STS movements among 4 arm placement conditions (arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) in ambulatory patients with SCI.
  • To investigate reliability (inter-rater, intra-rater, and test-retest), standard error of measurement and minimal detectable changes of the STSST and FTSST in ambulatory patients with SCI.
  • To investigate concurrent validity and factors associated with ability of the STSST and FTSST in ambulatory patients with SCI.
  • To investigate the ability of the STSST and FTSST to predict the risk of falls over 1, 3 and 6 months in ambulatory patients with SCI.
  • To investigate internal and external responsiveness of the STSST and FTSST to detect changes on walking ability over 1, 3 and 6 months in ambulatory patients with SCI.
  • To estimate the minimal clinically important difference or clinical significance of the FTSST in ambulatory patients with SCI.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 182 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Appropriate Methods and Psychometric Properties of Sit-to-stand Test in Ambulatory Patients With Spinal Cord Injury
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 10, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Ambulatory patients with SCI
  • Age at least 18 years
  • Body mass index (BMI) between 18.5 - 29.9 kg/m2
  • Having an incomplete SCI from traumatic or non-traumatic causes
  • Ability of independent standing up from a chair with or without hand support
  • Ability of independent walking with or without walking device over at least 10 meters continuously.
  • Ability to follow commands used in the studies



Primary Outcome Measures :
  1. Ability to perform single and five times sit-to-stand test among 4 arm conditions [ Time Frame: Change over 6 months ]
    Ability to execute a single time sit-to-stand and time used for five times sit-to-stand


Secondary Outcome Measures :
  1. 10-meter walk test [ Time Frame: Change over 6 months ]
    Change in walking speed during 6-month follow-up

  2. Fall events [ Time Frame: Over 6 months ]
    Incidence of fall during 6-month follow-up

  3. Global rating of change score (GRC score) [ Time Frame: Change over 6 months ]
    Level of change in subjects' independence in activities of daily life. The GRC score is divided into 15-point scale from "-7" (a very great deal worse) to "0" (about the same/ not change) to "7" (a very great deal better).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is conducted in patients with spinal cord injury who able to sit-to-stand independently with or without hand support from the Srinagarind hospital and communities in the Northeast areas of Thailand.
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 18.5 - 29.9 kg/m2
  • Having an incomplete SCI from traumatic or non-traumatic causes
  • Ability of independent standing up from a chair with or without hand support
  • Ability of independent walking with or without walking device over at least 10 meters continuously.
  • Ability to follow commands used in the studies

Exclusion Criteria:

Any ambulatory individuals with incomplete SCI who present signs and symptoms that might affect ability to perform STST will be excluded from the study such as

  • Pain in the muscles or joints with an intensity of pain more than 5 out of 10 on a numeric rating scale (NRS)
  • Joint deformities that affect mobility
  • Other neurological disorders such as having brain lesions
  • Unstable medical conditions
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625193


Contacts
Contact: Lalita Khuna, PhD student +66637391999 lalitakhuna@gmail.com

Locations
Thailand
Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District Recruiting
Khon Kaen, Thailand, 40002
Contact: Lalita Khuna    +66637391999    lalitakhuna@gmail.com   
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Sugalya Amatachaya, PhD School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.

Responsible Party: Sugalya Amatachaya, Assoc. Prof. Dr., Khon Kaen University
ClinicalTrials.gov Identifier: NCT03625193     History of Changes
Other Study ID Numbers: PHD02232558
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sugalya Amatachaya, Khon Kaen University:
Sit-to-stand test
Psychometric properties

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System